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510(k) Filed for LumiraDx Covid Test

[ Price : $8.95]

LumiraDx files a 510(k) to gain clearance for its five-minute Covid Ultra Test and the LumiraDx Instrument.

FDA Allows 1st Master File Use for Sterilizer

[ Price : $8.95]

FDA accepts the first master file for participation in the 510(k) Ethylene Oxide Sterility Change Master File Pilot Program.

FDA WEBVIEW CLOSED JULY 4TH WEEK

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In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Mo...

Patient Guides for Orthopedic Implants

[ Price : $8.95]

Federal Register notice: FDA announces the availability of the draft guidance entitled Patient-Matched Guides to Orthopedic Implan...

Rhinosinusitis Drug Development Guidance

[ Price : $8.95]

FDA publishes a guidance to help in the development of drug and biological products to treat chronic rhinosinusitis with nasal pol...

Compounding Inspection, Oversight FAQs

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The FDA Compounding Quality Center of Excellence posts 14 questions and answers about compounding inspections and oversight.

FDA OKs 1st Diabetes Cellular Therapy

[ Price : $8.95]

FDA approves CellTrans Lantidra, the first cellular therapy to treat some patients with Type 1 diabetes.

Info Collection on Advisory Committee Regs

[ Price : $8.95]

Federal Register notice: FDA sends an information collection revision to OMB entitled FDA Advisory Committee Regulations."

Info Collection on Device Conformity Assessments

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Federal Register notice: FDA sends to OMB an information collection revision entitled Accreditation Scheme for Conformity Assessme...

18-Page FDA-483 on Ipca Laboratories Inspection

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FDA releases the form FDA-483 with 11 observations from an inspection at Indias Ipca Laboratories Ratlam API facility.